Home Biofeedback Therapy for Bowel and Urinary Incontinence

(Bioanatoner Trial)

Overseen By Bianca Marsh, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Augusta University

Must not be taking: Opioids

Disqualifiers: Severe cardiac, renal, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

72 Participants Needed

Trial Summary

What is the purpose of this trial?

Biofeedback therapy is an effective treatment for the management of patients with dyssynergic defecation and constipation, urinary incontinence (UI), and fecal incontinence (FI). It is labor-intensive, costly, requires multiple office or hospital visits, is not easily available to the vast majority of patients in the community, and is not covered by many insurance companies. The purpose of this study is to 1. Evaluate home biofeedback therapy for patients with either constipation and dyssynergic defecation or urinary leakage or stool leakage by assessing the efficacy and safety of a wireless anorectal biofeedback device, and a cellphone app-based and voice guided home biofeedback training system 2. To compare the efficacy and safety of home biofeedback therapy system with the standard of care, office biofeedback therapy 3. To assess the cost-effectiveness of home biofeedback therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using opioids, you must not have used them in the past two weeks for constipation and dyssynergic defecation, or you must be on a stable dose for more than three months for fecal incontinence.

What data supports the effectiveness of the treatment Home Biofeedback Therapy for Bowel and Urinary Incontinence?

Research shows that biofeedback therapy can be effective for managing pelvic floor disorders and fecal incontinence, with about 60% of patients experiencing long-term improvement. Additionally, combining biofeedback with physiotherapy has shown better results for urinary incontinence compared to physiotherapy alone. ^{1 2 3 4 5}

Is home biofeedback therapy safe for treating bowel and urinary incontinence?

Research indicates that home biofeedback therapy is generally safe for treating conditions like urinary and fecal incontinence. It is considered a safe and effective method when used for pelvic floor issues, and no significant safety concerns have been reported in the studies. ^{4 6 7 8 9}

How is home biofeedback therapy different from other treatments for bowel and urinary incontinence?

Home biofeedback therapy is unique because it allows patients to manage their bowel and urinary incontinence at home using technology, making it more accessible and less resource-intensive than traditional office-based biofeedback therapy. This approach is particularly beneficial for younger patients who are comfortable with technology and prefer self-management. ^{1 4 5 10 11}

Research Team

Satish Rao, MD, PhD

Principal Investigator

Augusta University

Eligibility Criteria

This trial is for individuals with bowel or urinary incontinence, or bedwetting. Participants must have had symptoms for several months and meet specific diary criteria. Those with constipation need to fit the Rome IV criteria and show a certain pattern on tests. People can't join if they have related structural diseases, severe health conditions, are using opioids recently, or are pregnant/nursing.

Inclusion Criteria

If you have trouble controlling your bowel movements, you must have had frequent episodes for at least six months and report at least one episode per week on a poop diary.

If you have trouble controlling your bladder, you need to have had ongoing issues for at least three months and your daily records of accidents need to match certain guidelines.

I have constipation due to muscle coordination issues, confirmed by a special test.

Exclusion Criteria

I have fecal incontinence but do not have severe diarrhea, depression, certain illnesses, rectal issues, or am not pregnant/nursing.

I do not have ongoing urine leakage, depression, certain illnesses, rectal issues, or am not pregnant/nursing.

I have constipation without any major health issues, recent opioid use, or pregnancy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Home Biofeedback Therapy (HBT) or Office Biofeedback Therapy (OBT) for 6 weeks. HBT involves daily practice at home, while OBT involves weekly office visits.

6 weeks

HBT: Daily practice at home; OBT: 1 visit per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 and 12 weeks.

6 weeks

Assessments at 6 and 12 weeks

Long-term Follow-up

Participants are monitored for long-term outcomes, including the number of complete spontaneous bowel movements and episodes of fecal and urinary incontinence.

12 weeks

Treatment Details

Interventions

• Home Biofeedback therapy
• Office biofeedback therapy

Trial Overview The study is testing home biofeedback therapy using wireless devices and apps against office-based therapy to treat defecation issues and incontinence. It aims to see which method is more effective, safer, and cost-efficient by comparing patient outcomes from both treatments.

Participant Groups

Group I: Home Biofeedback Therapy (HBT) Experimental Treatment 1 Intervention

1. HBT for patients with constipation and dyssynergic defecation: 2. HBT for patients with FI 3. HBT for patients with UI All patients will be advised to practice HBT at least once or twice a day for six weeks.

Group II: Office Biofeedback Therapy (OBT) Active Control 1 Intervention

1. OBT for patients with constipation and dyssynergic defecation. 2. OBT for patients with FI. 3. OBT for patients with UI. All patients will receive office biofeedback, once weekly, over six weeks.

Home Biofeedback therapy is already approved in United States, European Union for the following indications:

Approved in United States as Biofeedback Therapy for:

• Dyssynergic Defecation
• Constipation
• Urinary Incontinence
• Fecal Incontinence

Approved in European Union as Biofeedback Therapy for:

• Fecal Incontinence
• Constipation
• Urinary Incontinence

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials

219

Recruited

85,900+

Findings from Research

Home biofeedback therapy (HBT) for fecal incontinence (FI) is as effective as office biofeedback therapy (OBT), showing significant reductions in weekly FI episodes after 6 weeks of treatment.

HBT not only improved FI symptoms but also enhanced quality of life and anal sphincter pressures, making it a safe and accessible alternative to traditional office-based therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of home biofeedback therapy versus office biofeedback therapy for fecal incontinence. Xiang, X., Sharma, A., Patcharatrakul, T., et al.[2022]

Biofeedback therapy (BFT) is effective for managing pelvic floor disorders, including defecatory disorders and fecal incontinence, but only about 60% of patients experience long-term improvement even in controlled trials.

Recent studies suggest that patients with lower bowel satisfaction scores and those using digital maneuvers tend to have better outcomes with BFT, making it a recommended option for those who do not respond to conservative treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Practical Guide to Biofeedback Therapy for Pelvic Floor Disorders. Narayanan, SP., Bharucha, AE.[2020]

Biofeedback therapy was effective in improving voluntary sphincter function in three out of four patients with fecal incontinence after surgery for anorectal malformations, particularly after three or four training sessions.

The therapy is recommended for patients with adequate resting and pressure in the sphincter, but may not be suitable for those with severely underdeveloped sphincters, indicating a need for careful patient selection before considering further surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback therapy for fecal incontinence after surgery for anorectal malformations: preliminary results. Iwai, N., Nagashima, M., Shimotake, T., et al.[2019]

In a study of 75 participants with fecal incontinence, supplementary home-based biofeedback using a Peritron perineometer significantly improved quality of life, particularly in younger individuals, compared to standard biofeedback alone.

While overall clinical improvements were limited, younger participants showed notable enhancements in continence and quality of life, indicating that home biofeedback can be a beneficial self-management tool for this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplementary home biofeedback improves quality of life in younger patients with fecal incontinence. Bartlett, L., Sloots, K., Nowak, M., et al.[2015]

In a study of 40 women with urinary stress incontinence, those who received physiotherapy combined with biofeedback showed significantly better improvement compared to those who only received physiotherapy, as measured by a standardized pad-weighing test.

The long-term outcomes after 2-3 years indicated that the biofeedback group not only had better results but also reported higher motivation for continued training, suggesting a lasting positive impact of the biofeedback intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback and physiotherapy versus physiotherapy alone in the treatment of genuine stress urinary incontinence. Glavind, K., Nøhr, SB., Walter, S.[2019]

Home biofeedback is as effective as supervised pelvic floor physical therapy (PFPT) for treating stress urinary incontinence (SUI) in women, with both methods showing significant improvements in quality of life after 3 months.

While home biofeedback was noninferior to PFPT in reducing incontinence severity, PFPT showed greater improvement in overactive bladder symptoms, indicating that both treatments have unique benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Biofeedback Versus Physical Therapy for Stress Urinary Incontinence: A Randomized Trial. Barnes, KL., Cichowski, S., Komesu, YM., et al.[2022]

Pelvic floor muscle exercises combined with biofeedback are a safe and effective treatment for urinary incontinence, but many patients struggle to complete the program.

Keeping a 7-day bladder diary was identified as the only significant predictor of whether patients would finish the treatment program, highlighting its importance in encouraging adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study to determine predictors of behavioral treatment completion for urinary incontinence. Kincade, JE., Peckous, BK., Busby-Whitehead, J.[2010]

Pelvic floor biofeedback therapy is a safe and effective treatment for conditions like chronic constipation, urinary incontinence, fecal incontinence, and pelvic floor pain, particularly for patients without severe pelvic organ prolapse or neurogenic defects.

The therapy's success is enhanced when patients have good mental cognition and adhere to treatment, with training focusing on muscle targeting, coordination, and strength, and its effectiveness evaluated through various symptoms and patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pelvic floor biofeedback therapy in pelvic floor diseases]. Ding, S.[2018]

In a study of 28 patients with stress and urge urinary incontinence, biofeedback treatment showed moderate effectiveness, successfully treating 36% of patients with stress incontinence and 43% with urgency incontinence, with durable results over time.

Biofeedback led to significant reductions in daytime frequency and nocturia, indicating its potential benefits, although it is less likely to become a popular treatment option compared to other more successful therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback for the treatment of stress and urge incontinence. Stein, M., Discippio, W., Davia, M., et al.[2019]

Biofeedback treatment for urinary incontinence is a low-risk and effective management option for certain patients, highlighting its therapeutic potential.

The described biofeedback technique uses external anal sphincter electromyography to provide clear visual and audio feedback, making it adaptable to individual patient needs and easily understandable for those with voiding dysfunctions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback therapy technique for treatment of urinary incontinence. O'Donnell, PD., Doyle, R.[2019]

Biofeedback therapy has become an effective treatment option for constipation and fecal incontinence, utilizing operant conditioning techniques to help patients regain control over their bowel functions.

The success of biofeedback therapy relies heavily on the motivation of both patients and instructors, leading to significant improvements in patients' quality of life and sustained benefits over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Biofeedback therapy for constipation and fecal incontinence]. Ciochină, AD., Drug, VL.[2011]

References

1. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of home biofeedback therapy versus office biofeedback therapy for fecal incontinence. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Practical Guide to Biofeedback Therapy for Pelvic Floor Disorders. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Biofeedback therapy for fecal incontinence after surgery for anorectal malformations: preliminary results. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Supplementary home biofeedback improves quality of life in younger patients with fecal incontinence. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Biofeedback and physiotherapy versus physiotherapy alone in the treatment of genuine stress urinary incontinence. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Home Biofeedback Versus Physical Therapy for Stress Urinary Incontinence: A Randomized Trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A pilot study to determine predictors of behavioral treatment completion for urinary incontinence. [2010]

8. China pubmed.ncbi.nlm.nih.gov

[Pelvic floor biofeedback therapy in pelvic floor diseases]. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Biofeedback for the treatment of stress and urge incontinence. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Biofeedback therapy technique for treatment of urinary incontinence. [2019]

11. Romania pubmed.ncbi.nlm.nih.gov

[Biofeedback therapy for constipation and fecal incontinence]. [2011]